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Topical SGX302 for Mild-to-Moderate Psoriasis

S

Soligenix

Status and phase

Enrolling
Phase 2

Conditions

Psoriasis
Plaque Psoriasis
Psoriasis Vulgaris

Treatments

Drug: Placebo
Drug: Hypericin

Study type

Interventional

Funder types

Industry

Identifiers

NCT05442190
HPN-PSR-01

Details and patient eligibility

About

To evaluate SGX302 (topical hypericin ointment) with visible light in an initial 18-week treatment course for improving lesions in patients with mild-to-moderate psoriasis.

Enrollment

42 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6-months duration that involves the body (trunk and/or limbs) that is amenable to topical treatment and opaque coverage after application.
  • Have a static Investigator Global Assessment (IGA)/Psoriasis Area and Severity Index (PASI) of disease severity of mild or moderate on the body (trunk and/or limbs).
  • Have lesions involving 2-30% of the body (trunk and/or limbs). For subjects with scalp psoriasis included in the treatment area, the total treatment area on body and scalp must not exceed 30%.

Exclusion criteria

  • Use of topical anti psoriatic therapy within one week prior to the beginning of the study and willing to not use other psoriasis treatments for 4 weeks following completion of the treatment portion of the study.
  • Received systemic biologic therapy to treat psoriasis within 12 weeks prior to the beginning of the study.
  • Received systemic psoriasis therapy within 4 weeks prior to the beginning of the study.
  • Received phototherapy (including laser) or photodynamic (light activated drug) therapy within 4 weeks prior to the beginning of the study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

42 participants in 2 patient groups, including a placebo group

SGX302 (Ointment with 0.25 % Hypericin)
Experimental group
Description:
SGX302 (0.25 % hypericin) ointment will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks.
Treatment:
Drug: Hypericin
Placebo (Ointment without Hypericin)
Placebo Comparator group
Description:
Placebo ointment will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Christopher Pullion, DO

Data sourced from clinicaltrials.gov

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